A Study of Leuprolide to Treat Prostate Cancer

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Hormones; Leuprolide; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• Voluntarily sign an IRB-approved informed consent form and any required privacy statement/authorization form.

• Pre-trial serum testosterone level >150 ng/dL.

• Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM* classification cT1b-4, N: any, M: any.

*Tumor/Nodes/Metastases

• Subjects with a rising PSA following radical prostatectomy defined as an increase of 0.2 ng/mL from the previous test on two consecutive testings or rising PSA following prostate irradiation using Phoenix Definition of a rise of greater than or equal to 2.0 ng/mL above the nadir.

• Prostate cancer and general clinical status is sufficient to warrant at least 48 weeks of continuous androgen deprivation treatment, without concomitant antiandrogen treatment.

• Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2 at the time of pre-trial screening.

• Life expectancy of at least 18 months.

• Subjects with serum creatinine ≤1.9 mg/dL, bilirubin ≤2.0 mg/dL (unless Gilbert's syndrome with normal AST, ALT); AST and ALT ≤2.5 times the upper limit of normal.

Exclusion Criteria:

• Requires additional treatment including radical prostatectomy, radiotherapy or cryotherapy of local disease.

• Historical, clinical, or radiographic evidence of central nervous system metastases, including spinal cord metastasis.

• Clinical evidence of urinary tract obstruction.

• History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.

• History of clinical hypogonadism.

• Current malignancy or history of malignancy except for prostate cancer or basal or squamous cell carcinoma of the skin.

• Clinical or laboratory evidence of any severe underlying disease state (excluding prostate cancer) that would place subjects in additional jeopardy by participating in this trial.

• Hypersensitivity to leuprolide, polylactic acid, or any excipient of the drug.

• Incomplete recovery from the effects of any major surgery.

• History of receiving of the following prostate cancer therapies within 8 weeks prior to the Screening Visit: chemotherapy, immunotherapy, antiandrogen, radiation therapy, cryotherapy, strontium, or biological response modifiers.

• History of prostatic surgery within 4 weeks prior to the Screening Visit.

• Received hormonal therapy, including GnRH analogs (less than or equal to 6 month depot administration), estrogen, Megace and phytotherapy, within 32 weeks prior to the Screening Visit and during the trial.

• Alternative medical therapies which have an estrogenic, androgenic, or antiandrogenic effect (including phyto-estrogens and phyto-androgens) within 12 weeks prior to the Screening Visit and during the trial.

• Requires the chronic use of systemic corticosteroids and anticonvulsants that may affect bone loss such as carbamazepine, phenobarbital, phenytoin, valproic acid or primidone.

• May require antiandrogen, immuno-, or surgical therapy for prostate cancer during the trial.

• History of alcoholism or consumes >14 alcoholic beverages per week or illicit drug abuse within 12 months prior to screening.

• Received therapy with a GnRH analog (1 year implant) within 60 weeks prior to the Screening Visit.

• Received therapy with finasteride or ketoconazole within 1 week prior to the Screening Visit; dutasteride within 25 weeks prior to the Screening Visit.